Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
This is an increase over the number of companies cited in the previous year.
The citations in the county include:
- You did not routinely calibrate the automated, mechanical, or electronic equipment to ensure proper performance.
- You did not establish component specifications for purity, strength and composition.
- You did not establish product specifications for limits on contamination that may adulterate, or that may lead to adulteration of, the finished dietary supplement.
The company cited was involved in the Food and Cosmetics sector.
The company cited should take a voluntary action to correct its managing operations.
The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.
According to its website, the FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Dert, Inc. | Food and Cosmetics | 07/17/2024 | Equipment - automated - calibrate, inspect |
| Dert, Inc. | Food and Cosmetics | 07/17/2024 | Specifications-component purity, strength, composition |
| Dert, Inc. | Food and Cosmetics | 07/17/2024 | Specifications - contamination limits |
| Dert, Inc. | Food and Cosmetics | 07/17/2024 | Specifications - identity, purity, strength, composition |
| Dert, Inc. | Food and Cosmetics | 07/17/2024 | Appropriate tests, examinations; certificate of analysis |
| Dert, Inc. | Food and Cosmetics | 07/17/2024 | Component - qualify supplier |
| Dert, Inc. | Food and Cosmetics | 07/17/2024 | Specifications - representative samples; finished batch |
| Dert, Inc. | Food and Cosmetics | 07/17/2024 | Master manufacturing record - specific actions; quality |
| Dert, Inc. | Food and Cosmetics | 11/12/2024 | Production, process controls - implement |
| Dert, Inc. | Food and Cosmetics | 11/12/2024 | Specifications - components |
| Dert, Inc. | Food and Cosmetics | 11/12/2024 | Specifications - finished dietary supplement |
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